{"id":516,"date":"2020-03-05T08:54:36","date_gmt":"2020-03-05T07:54:36","guid":{"rendered":"http:\/\/www2.uskvbl.sk\/?page_id=516"},"modified":"2026-04-02T10:33:26","modified_gmt":"2026-04-02T08:33:26","slug":"preznacovanie-a-dopredaj","status":"publish","type":"page","link":"https:\/\/www.uskvbl.sk\/?page_id=516","title":{"rendered":"PREZNA\u010cOVANIE A DOPREDAJ"},"content":{"rendered":"\n<h3 class=\"wp-block-heading\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\"><strong>Dopredaj veterin\u00e1rneho lieku<\/strong><\/mark><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Po zru\u0161en\u00ed registr\u00e1cie<\/strong><\/li>\n<\/ul>\n\n\n\n<p>Dr\u017eite\u013e povolenia na ve\u013ekoobchodn\u00fa distrib\u00faciu veterin\u00e1rnych liekov m\u00f4\u017ee po\u017eiada\u0165 \u00da\u0160KVBL o povolenie v\u00fdnimky na dopredaj veterin\u00e1rneho lieku po zru\u0161en\u00ed registr\u00e1cie za predpokladu, \u017ee \u017eiados\u0165 o v\u00fdnimku na dopredaj tak\u00e9ho veterin\u00e1rneho lieku je od\u00f4vodnen\u00e1 (\u00a7 18 ods. 27 z\u00e1kona 362\/2011 Z. z.)<\/p>\n\n\n\n<p>\u00da\u0160KVBL akceptuje aj po\u017eiadavku na dopredaj predlo\u017een\u00fa dr\u017eite\u013eom rozhodnutia o&nbsp;registr\u00e1cii, priamo v&nbsp;\u017eiadosti o&nbsp;zru\u0161enie registr\u00e1cie. V \u017eiadosti mus\u00ed dr\u017eite\u013e rozhodnutia o registr\u00e1cii uvies\u0165 \u010d\u00edslo \u0161ar\u017ee, d\u00e1tum exspir\u00e1cie, po\u010det a&nbsp;ve\u013ekos\u0165 balen\u00ed.<\/p>\n\n\n\n<p>\u00da\u0160KVBL v rozhodnut\u00ed, ktor\u00fdm povol\u00ed v\u00fdnimku na dopredaj veterin\u00e1rneho lieku, ur\u010d\u00ed podmienky uplatnenia v\u00fdnimky na dopredaj veterin\u00e1rneho lieku.<\/p>\n\n\n\n<p>Po zru\u0161en\u00ed registr\u00e1cie sa prezna\u010dovanie veterin\u00e1rneho lieku nevy\u017eaduje.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pri zmene registr\u00e1cie<\/strong><\/li>\n<\/ul>\n\n\n\n<p>Dr\u017eite\u013e rozhodnutia o registr\u00e1cii veterin\u00e1rneho lieku alebo dr\u017eite\u013e povolenia na ve\u013ekoobchodn\u00fa distrib\u00faciu veterin\u00e1rnych liekov m\u00f4\u017eu po\u017eiada\u0165 \u00da\u0160KVBL o v\u00fdnimku na dopredaj veterin\u00e1rneho lieku nad r\u00e1mec povolen\u00e9ho \u010dasu uveden\u00e9ho v rozhodnut\u00ed o zmene registr\u00e1cie veterin\u00e1rneho lieku. \u017diados\u0165 o v\u00fdnimku na dopredaj veterin\u00e1rneho lieku mus\u00ed by\u0165 n\u00e1le\u017eite od\u00f4vodnen\u00e1 (\u00a7 98 ods. 2 p\u00edsm. h) resp. \u00a7 18 ods. 27 z\u00e1kona 362\/2011 Z. z.).<\/p>\n\n\n\n<p>\u00da\u0160KVBL v rozhodnut\u00ed, ktor\u00fdm povol\u00ed v\u00fdnimku na dopredaj veterin\u00e1rneho lieku, ur\u010d\u00ed podmienky uplatnenia v\u00fdnimky na dopredaj veterin\u00e1rneho lieku.<\/p>\n\n\n\n<p>Pri dopredaji z&nbsp;d\u00f4vodu zmeny registr\u00e1cie veterin\u00e1rneho lieku m\u00f4\u017ee \u00da\u0160KVBL vy\u017eadova\u0165 prezna\u010dovanie veterin\u00e1rneho lieku (z&nbsp;d\u00f4vodu ochrany zdravia zvierat, zdravia \u013eud\u00ed a\/alebo ochrany \u017eivotn\u00e9ho prostredia).<\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-ba80a7f9-f58d-4e87-8a3f-a465729922be\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/F88a_ziadost_o_udelenie_vynimky_dopredaj.docx\">\u017diados\u0165 o\u00a0povolenie v\u00fdnimky &#8211; dopredaj veterin\u00e1rneho lieku<\/a><\/div>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">Dovoz mal\u00e9ho mno\u017estva veterin\u00e1rneho lieku v inom jazyku a prezna\u010dovanie<\/mark><\/strong><\/h3>\n\n\n\n<p>Dr\u017eite\u013e povolenia na ve\u013ekodistrib\u00faciu liekov v pr\u00edpade z\u00e1meru doviez\u0165 veterin\u00e1rne lieky od dr\u017eite\u013ea rozhodnutia o registr\u00e1cii v inom ako v \u0161t\u00e1tnom jazyku je povinn\u00fd poda\u0165 \u00da\u0160KVBL \u017eiados\u0165 o povolenie v\u00fdnimky na dovoz mal\u00e9ho mno\u017estva veterin\u00e1rneho lieku v inom jazyku a z\u00e1rove\u0148 po\u017eiada\u0165 o \u00fapravu vonkaj\u0161ieho obalu, vn\u00fatorn\u00e9ho obalu a p\u00edsomnej inform\u00e1cie pre pou\u017e\u00edvate\u013eov. \u017diados\u0165 o povolenie v\u00fdnimky mus\u00ed by\u0165 od\u00f4vodnen\u00e1 (\u00a7 18 ods. 25 z\u00e1kona 362\/2011 Z. z.)<\/p>\n\n\n\n<p>Ak je veterin\u00e1rny liek ur\u010den\u00fd len na podanie veterin\u00e1rnym lek\u00e1rom, \u00da\u0160KVBL m\u00f4\u017ee udeli\u0165 v\u00fdnimku, aby p\u00edsomn\u00e1 inform\u00e1cia pre pou\u017e\u00edvate\u013ea veterin\u00e1rneho lieku nebola v \u0161t\u00e1tnom jazyku (\u00a7 18 ods. 26 z\u00e1kona 362\/2011 Z. z.)<\/p>\n\n\n\n<p>\u00da\u0160KVBL v rozhodnut\u00ed, ktor\u00fdm povol\u00ed v\u00fdnimku, ur\u010d\u00ed podmienky uplatnenia v\u00fdnimky na dovoz veterin\u00e1rneho lieku v inom jazyku.<\/p>\n\n\n\n<p>\u00da\u0160KVBL posudzuje ka\u017ed\u00fa \u017eiados\u0165 o&nbsp;povolenie v\u00fdnimky individu\u00e1lne. Pri posudzovan\u00ed \u017eiadosti sa zoh\u013ead\u0148uje hlavne:<\/p>\n\n\n\n<ol style=\"list-style-type:lower-alpha\" class=\"wp-block-list\">\n<li>d\u00f4vod dovozu,<\/li>\n\n\n\n<li>mo\u017enosti nahradenia v\u00fdpadku produktu in\u00fdm produktom,<\/li>\n\n\n\n<li>mno\u017estvo lieku dovezen\u00e9ho na v\u00fdnimku v minulosti,<\/li>\n\n\n\n<li>druh zvierat, pre ktor\u00fd je liek ur\u010den\u00fd (minoritn\u00e9, majoritn\u00e9 druhy),<\/li>\n\n\n\n<li>\u010di ide o do\u010dasn\u00e9 rie\u0161enie, k\u00fdm bude dostupn\u00e1 slovensk\u00e1 verzia obalu.<\/li>\n<\/ol>\n\n\n\n<p>Mal\u00fdm mno\u017estvom veterin\u00e1rneho lieku sa vo v\u0161eobecnosti rozumie limitovan\u00e1 z\u00e1sielka na preklenutie situ\u00e1cie &#8211; v\u00fdnimo\u010dn\u00e9 alebo do\u010dasn\u00e9 zabezpe\u010denie konkr\u00e9tneho lieku, ktor\u00fd m\u00e1 pokry\u0165 konkr\u00e9tnu potrebu (napr. nedostatok in\u00e9ho veterin\u00e1rneho lieku na rovnak\u00fa indik\u00e1ciu\/cie\u013eov\u00fd druh na trhu SR).<\/p>\n\n\n\n<p>Pr\u00edklady mal\u00e9ho mno\u017estva:<\/p>\n\n\n\n<ol style=\"list-style-type:lower-alpha\" class=\"wp-block-list\">\n<li>nieko\u013eko balen\u00ed alebo limitovan\u00e1 \u0161ar\u017ea (mal\u00e1 \u0161ar\u017ea alebo mno\u017estvo na nieko\u013eko t\u00fd\u017ed\u0148ov distrib\u00facie),<\/li>\n\n\n\n<li>mno\u017estvo potrebn\u00e9 pre konkr\u00e9tne veterin\u00e1rne pracovisko alebo mal\u00fd po\u010det zvierat,<\/li>\n\n\n\n<li>mno\u017estvo na preklenutie v\u00fdpadku vhodn\u00e9ho lieku, k\u00fdm bude dostupn\u00fd slovensk\u00fd obal lieku, o\u00a0povolenie v\u00fdnimky ktor\u00e9ho sa \u017eiada.<\/li>\n<\/ol>\n\n\n\n<p>zvy\u010dajne v rozsahu:<\/p>\n\n\n\n<ol style=\"list-style-type:lower-alpha\" class=\"wp-block-list\">\n<li>do 1000 balen\u00ed (zvy\u010dajne do 10\u00a0000 d\u00e1vok) \u2013 pri liekoch pre majoritn\u00e9 druhy zvierat (hov\u00e4dz\u00ed dobytok, ovce chovan\u00e9 na m\u00e4so, o\u0161\u00edpan\u00e9, kur\u010dat\u00e1, psy a\u00a0ma\u010dky),<\/li>\n\n\n\n<li>do 100 balen\u00ed (zvy\u010dajne do 2 500 d\u00e1vok) \u2013 pri liekoch pre ostatn\u00e9 druhy zvierat.<\/li>\n<\/ol>\n\n\n\n<p>\u00da\u0160KVBL nebude akceptova\u0165 opakovan\u00e9 \u017eiadosti o&nbsp;udelenie v\u00fdnimky z&nbsp;d\u00f4vodu nedostupnosti lieku v&nbsp;obaloch v&nbsp;slovenskom jazyku, ak je na trhu dostupn\u00fd in\u00fd produkt na rovnak\u00fa indik\u00e1ciu a&nbsp;cie\u013eov\u00fd druh v balen\u00ed v&nbsp;slovenskom jazyku.<\/p>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-984fe133-d503-4cd7-b733-cd283741f419\" href=\"https:\/\/www.uskvbl.sk\/wp-content\/uploads\/F88b_ziadost_o_udelenie_vynimky_cudzojazycne_obaly.docx\">\u017diados\u0165 o\u00a0povolenie v\u00fdnimky &#8211; dovoz mal\u00e9ho mno\u017estva veterin\u00e1rneho lieku v inom jazyku a prezna\u010denie<\/a><\/div>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">Sp\u00f4sob pod\u00e1vania \u017eiadost\u00ed<\/mark><\/strong><\/h3>\n\n\n\n<p>\u017diadosti o&nbsp;dopredaj veterin\u00e1rneho lieku a dovoz mal\u00e9ho mno\u017estva veterin\u00e1rneho lieku v inom jazyku a prezna\u010dovanie<strong> sa pod\u00e1vaj\u00fa individu\u00e1lne t. j. pre ka\u017ed\u00fd veterin\u00e1rny liek osobitne.<\/strong><\/p>\n\n\n\n<p><strong>\u017diados\u0165 je potrebn\u00e9 posla\u0165 na \u00da\u0160KVBL cez \u00fastredn\u00fd port\u00e1l verejnej spr\u00e1vy \u201eSlovensko.sk\u201c alebo emailom na adresu: <\/strong><a href=\"mailto:podatelna@uskvbl.sk\">podatelna@uskvbl.sk<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Dopredaj veterin\u00e1rneho lieku Dr\u017eite\u013e povolenia na ve\u013ekoobchodn\u00fa distrib\u00faciu veterin\u00e1rnych liekov m\u00f4\u017ee po\u017eiada\u0165 \u00da\u0160KVBL o povolenie v\u00fdnimky na dopredaj veterin\u00e1rneho lieku po zru\u0161en\u00ed registr\u00e1cie za predpokladu, \u017ee \u017eiados\u0165 o v\u00fdnimku na dopredaj tak\u00e9ho veterin\u00e1rneho lieku je od\u00f4vodnen\u00e1 (\u00a7 18 ods. 27 &hellip; <a href=\"https:\/\/www.uskvbl.sk\/?page_id=516\">Pokra\u010dova\u0165 v \u010d\u00edtan\u00ed <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-516","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/516","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=516"}],"version-history":[{"count":7,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/516\/revisions"}],"predecessor-version":[{"id":9559,"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=\/wp\/v2\/pages\/516\/revisions\/9559"}],"wp:attachment":[{"href":"https:\/\/www.uskvbl.sk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=516"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}